Sun Pharma and Philogen sign global licensing agreement for Fibromun EP News Bureau Oct 1, 2024 Agreement focuses on global commercialisation of anti-cancer immunotherapy
What effect does X-ray inspection have on pharma products? Mike Pipe Aug 8, 2024 Pharma manufacturers continue to have concerns over the effect that X-ray inspection could have on their medicines. Are they right…
Dr Reddy’s receives positive CHMP opinion for biosimilar Rituximab candidate in European markets EP News Bureau Jul 29, 2024 Dr Reddy's Rituximab biosimilar DRL_RI (ITUXREDI) progresses towards European approval with EMA CHMP endorsement
Submission of Nidlegy marketing authorisation application validated by EMA EP News Bureau Jul 4, 2024 The first marketing authorisation application of Nidlegy for the treatment of locally advanced fully resectable melanoma was…
EMA approval of Sanofi/Regeneron’s Dupixent fills biologic gap in COPD: GlobalData GlobalData Jul 4, 2024 Dupixent shows promise for COPD, new treatment option reduces flare - ups and improves breathing
AstraZeneca’s COVID prevention drug application gets EU fast-track assessment Reuters Jul 1, 2024 An accelerated assessment aims to speed up the European Medicines Agency’s (EMA) review of a market authorisation application
EMA approves Biocon’s new mAbs facility in India EP News Bureau Jun 24, 2024 EMA also renews GMP certifications for Biocon’s India and Malaysia sites
Orchid Pharma gets EMA approval for Exblifep EP News Bureau Jan 30, 2024 Exblifep has received EMA's recommendation for marketing authorization for use in treatment of complicated urinary tract…
Biocon Biologics gets EC approval for YESAFILI, biosimilar Aflibercept EP News Bureau Sep 20, 2023 The EC decision follows the European Medicines Agency’s CHMP positive opinion recommending approval of YESAFILI in July
Biocon Biologics gets positive CHMP opinion for YESAFILI, biosimilar Aflibercept EP News Bureau Jul 24, 2023 YESAFILI is intended for the treatment of neovascular age-related macular degeneration, visual impairment due to macular oedema…